Pediatric nephrolithiasis is an increasing health problem, with rising prevalence particularly in certain geographic regions. Management options for pediatric renal stones include extracorporeal shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL), and retrograde intrarenal surgery. According to the EAU/ESPU guidelines, SWL is recommended as a first-line treatment for most renal stones; however, its success is significantly influenced by stone size, location, and density. High-density renal stones (≥1000 Hounsfield Units) are associated with lower stone-free rates after SWL and higher retreatment rates. Miniaturized percutaneous nephrolithotomy (mini-PNL) has emerged as an effective alternative, offering high stone-free rates with reduced morbidity compared to standard PNL due to the use of smaller access sheaths. While adult studies have demonstrated superior outcomes of mini-PNL over SWL for high-density renal stones, there is a lack of comparative data in the pediatric population. This prospective randomized controlled study aims to compare the efficacy and safety of mini-PNL versus SWL in children aged 2 to 12 years with single, non-lower pole, high-density (≥1000 HU), medium-sized (10-20 mm) renal stones. Eligible patients will be randomized into two equal groups to undergo either mini-PNL or SWL under general anesthesia. The primary outcome is the stone-free rate, defined as no residual stone or residual fragments ≤4 mm on non-contrast computed tomography performed three months after the procedure. Secondary outcomes include operative and fluoroscopy times, hemoglobin drop, length of hospital stay, retreatment and ancillary procedure rates, and postoperative complications graded according to the Clavien-Dindo classification. The study will be conducted at a single tertiary referral center. All participants' parents or legal guardians will provide informed consent in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. This study aims to provide evidence to guide optimal management of pediatric patients with high-density renal stones.
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Assess the efficacy assessed as stone free rate
Timeframe: 3 months